Sanofi and Alnylam are restructuring RNAi therapeutic alliance

Sanofi and RNAi therapeutics company, Alnylam Pharmaceuticals, have begun strategic restructuring of their RNAi therapeutics alliance to streamline and optimise development and commercialisation of certain products for the treatment of rare genetic diseases.

Restructuring

The restructuring will involve the following changes:

Sanofi will obtain global development and commercialisation rights to fitusiran, an investigational RNAi therapeutic, currently in development for the treatment of people with haemophilia A and B. Global commercialisation of fitusiran, upon approval, will be done by Sanofi Genzyme, the specialty care global business unit of Sanofi. Alnylam will receive royalties based on net sales of fitusiran products.

Alnylam will obtain global development and commercialisation rights to its investigational RNAi therapeutics programmes for the treatment of ATTR amyloidosis, including patisiran and ALN-TTRsc02. Sanofi will receive royalties based on net sales of these ATTR amyloidosis products.

With respect to other products falling under the RNAi therapeutics alliance, the material terms of the 2014 Alnylam-Sanofi Genzyme alliance remain unchanged.

“The restructured alliance reflects Sanofi Genzyme's sustained interest in the strong potential of Alnylam's portfolio of genetic medicines. The new structure simplifies operations, providing both parties the agility needed to make these medicines available to patients as quickly as possible once approved,” said Bill Sibold, executive vice president and head of Sanofi Genzyme. “This restructuring will enable both parties to maximize the value of each asset and allows us to maintain shared economics across the alliance programme.”

“This strategic restructuring enables streamlined development and an optimised approach to bringing innovative medicines to patients with ATTR amyloidosis and haemophilia around the world, maximising the commercial opportunities for these programmes,” said John Maraganore, PhD, chief executive officer of Alnylam. “For Alnylam, this provides strategic clarity and operational alignment with regard to the development and commercialization of patisiran and ALN-TTRsc02. This will allow us to develop both products in a comprehensive manner, potentially addressing the full spectrum of transthyretin-mediated amyloidosis disease treatment and prevention. At the same time, we will continue to support and benefit — via royalties — from the fitusiran opportunity through Sanofi's significant development and commercial leadership.”

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